Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Purpose
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Condition
- Asthma Acute
Eligibility
- Eligible Ages
- Between 12 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Physician-diagnosed asthma with duration of ≥12 months (based on the GINA 2024 Guidelines). - Currently receiving treatment with low, medium, to high dose ICS (equivalent ICS doses as per GINA 2024 Guidelines) in combination with at least 1 additional asthma controller medication for at least 60 days prior to the Screening. - Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening. - For participants who consent/assent to participate in the trial while in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL within 12 months prior to Screening. - Current acute asthma exacerbation requiring an urgent healthcare visit for treatment. - Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation. - Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation. - FEV1 ≥30% predicted prior to receiving IP.
Exclusion Criteria
- Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer. - Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. - Current or former smoker, has a smoking history including: If <30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years - COPD and other clinically significant pulmonary disease other than asthma. - Known or suspected history of immunosuppression. - History of known immunodeficiency disorder (including HIV-1 or HIV-2). Known medical history of hepatitis B or C. - History of alcohol abuse and/or drug abuse within 12 months prior to Screening. - History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >1 year prior to entry or other malignancies treated with apparent success with curative therapy >5 years prior to entry. - Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization. - Receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate) 30 days or 5 half-lives prior to randomization, whichever is longer. - Receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer. - Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial. - Participants that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1b. - Treatment with OCS and/or hospitalization for an exacerbation of asthma less than 4 weeks prior to randomization. - Receipt of any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer. The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rademikibart |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Synergy Healthcare
Bradenton, Florida 34209
Bradenton, Florida 34209
Contact:
Patrick Weston, MD
Patrick Weston, MD
More Details
- NCT ID
- NCT06940141
- Status
- Recruiting
- Sponsor
- Connect Biopharm LLC
Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.